Outcomes of Enhanced Recovery After Surgery (ERAS) vs. Standard of Care in Cesarean Deliveries: A Randomized-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Adverse composite outcome
研究概览
简要总结
In recent years, a set of evidence-based recommendations called Enhanced Recovery After Surgery (ERAS) is being applied for care of cesarean sections. The effectiveness of ERAS in reducing the length of hospitalization, postoperative complications, the need for analgesics right away after surgery, and the financial cost in the context of cesarean sections has been shown in several studies. There is strong evidence that following ERAS protocols aids postoperative recovery positively. This will be a randomized trial to determine if there is a difference regarding adverse maternal outcomes between ERAS group and standard of care.
详细描述
Cesarean section is one of the most common surgeries performed today with over one million performed in the United States annually. Our institiution is a tertiary maternity hospital with approximately 3500 cesarean sections annually. A standardized set of guidelines known as Enhanced Recovery After Surgery (ERAS) has been used in a variety of surgical specialties, including colorectal, urologic, gynecologic, and hepatobiliary surgery. The adoption of ERAS guidelines for the obstetric population now offers evidence-based recommendations for postoperative care following cesarean delivery.
At our institution, due to large volume of cesarean section, we encounter a variety of postoperative complications. Institutional standard of care for preoperative, intraoperative and postoperative care has been applied by all providers. In light of recent positive evidence when ERAS protocol is applied, our team aimed to design a randomized controlled trial for comparison of maternal outcomes in ERAS and standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women who had cesarean delivery
- •Gestational age >37/0 weeks
排除标准
- •Placenta accreta spectrum
- •Hypertensive disorders of pregnancy
- •Placental abruption
- •Need for emergent/urgent cesarean
- •Pregnancy complicated by an active infection
- •History of allergic reaction to diclofenac sodium, paracetamol or metoclopramide
结局指标
主要结局
Adverse composite outcome
时间窗: Within postoperative 48 hours
One or more of the following: Prolonged length of hospital stay, infectious complication (urinary tract, wound complications etc.), gastrointestinal complications (need for additional treatment for nausea-vomiting, delayed return of intestinal function, ileus etc.), thrombotic complications, readmission
次要结局
- Postoperative pain(At post operative 6th and 24th hour)
- Quality of recovery(Immediately before discharge)
研究者
gizem boz izceyhan
Gizem Boz İzceyhan, MD
Zeynep Kamil Maternity and Pediatric Research and Training Hospital